510(k) K190439 · NJD Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Engage Partial Knee System
| Applicant | Engage Uni, LLC, Winter Park FL, US |
| Decision | Substantially Equivalent, Nov 21, 2019 |
| Received | Feb 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190439
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2023 | Smith & Nephew, Inc. Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers:
a) REF 1-10003-100 (SIZE 1 Right Medial);
b) REF 1-10003-110 (SIZE 1 Left Medial);
c) REF 1-10003-200 Open, Classified |
HSX | None listed |
| May 31, 2023 | Smith & Nephew, Inc. Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee Open, Classified |
HSX | None listed |
| May 31, 2023 | Smith & Nephew, Inc. Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL;
b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL;
c) REF 1-10012-200, SIZE 2-LEF Open, Classified |
HSX | None listed |
| May 31, 2023 | Smith & Nephew, Inc. Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers:
a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM;
b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM;
c) REF 1-10013-111, SIZ Open, Classified |
HSX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.